Long Non-coding RNA (lncRNA) ZFAS1-Mediated Mechanism of Roasted Nux Vomica in Intervening Bortezomib-Induced Peripheral Neuropathy (ZFAS1-BIPN)
Study on the Intervention Effect of Roasted Nux Vomica on Bortezomib-Related Peripheral Neuropathy Based on lncRNA ZFAS1
This study aims to evaluate the efficacy and safety of Roasted Nux Vomica Capsules in the treatment of BIPN in patients with multiple myeloma.
A total of 22 patients with multiple myeloma who developed peripheral neuropathy after receiving bortezomib-based chemotherapy will be enrolled at the First Affiliated Hospital of Zhejiang Chinese Medical University. All patients will receive oral Roasted Nux Vomica Capsules at a dose of 0.4 g three times daily for 6 consecutive weeks.
The researchers will assess the severity of peripheral neuropathy assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0, traditional Chinese medicine symptom (TCM) scores, and neurotoxicity scores measured by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTx) scale at baseline (before treatment) and at 2, 4, and 6 weeks after starting treatment. The study will also explore the underlying mechanism of Roasted Nux Vomica in treating BIPN through the lncRNA ZFAS1 pathway.
This study has been approved by the Ethics Committee of the First Affiliated Hospital of Zhejiang Chinese Medical University (Approval Number: 2021-K-263-01).
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Study Background: Bortezomib is a first-line proteasome inhibitor for the treatment of multiple myeloma, but BIPN is one of its most common and dose-limiting adverse effects, which seriously affects the quality of life of patients and may lead to treatment discontinuation. Currently, there is no effective standard treatment for BIPN. Roasted Nux Vomica has been used in traditional Chinese medicine for centuries to treat pain and neurological disorders, and preliminary studies have shown its potential neuroprotective effects.
Study Design:This is a single-arm, open-label, prospective clinical study. A total of 22 eligible patients with multiple myeloma complicated with BIPN will be enrolled.
Intervention: All enrolled patients will receive oral Strychnos nux-vomica L. Capsules at a dose of 0.4 g three times daily for 6 consecutive weeks. All patients will continue to receive their original bortezomib-based chemotherapy regimen during the study period.
Outcome Measures
- Primary outcome: Change in NCI-CTCAE grade from baseline to weeks 2, 4, and 6.
- Secondary outcomes: Changes in TCM scores, FACT/GOG-NTx scale, and quality of life scores from baseline to weeks 2, 4, and 6.
- Exploratory outcome: Changes in the expression level of lncRNA ZFAS1 in peripheral blood mononuclear cells.
Ethical Considerations This study is conducted in accordance with the Declaration of Helsinki and has been approved by the Ethics Committee of the First Affiliated Hospital of Zhejiang Chinese Medical University. All patients will provide written informed consent before enrollment.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Zhejiang
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Hangzhou, Zhejiang, China, 310006
- The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine)
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
Confirmed diagnosis of multiple myeloma Developed peripheral neuropathy after receiving bortezomib-based chemotherapy Peripheral neuropathy meets the diagnostic criteria of bortezomib-induced peripheral neuropathy (BIPN) according to the 2015 Chinese Expert Consensus on the Diagnosis and Treatment of Multiple Myeloma Peripheral Neuropathy Aged between 18 and 85 years old Currently receiving bortezomib-based chemotherapy regimen Able to understand and sign the written informed consent form
Exclusion Criteria:
Prior use of nerve-damaging medications such as lenalidomide or thalidomide Severe cardiac, hepatic, or renal insufficiency (creatinine clearance ≤40 ml/min or serum creatinine ≥177 μmol/L) History of mental illness Known allergy or intolerance to Strychnos nux-vomica L. or any components of the study drug Pregnant or lactating women, or women planning to become pregnant Received other specific treatments for peripheral neuropathy within 4 weeks prior to enrollment Any medical condition that, in the investigator's judgment, may interfere with the study results or increase the risk to the participant
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Roasted Nux Vomica Capsules Intervention Group
All eligible patients with bortezomib-induced peripheral neuropathy (BIPN) received oral Roasted Nux Vomica Capsules at a dose of 0.4 g three times daily for 6 consecutive weeks.
All patients continued to receive their original bortezomib-based chemotherapy regimen during the study period.
Efficacy assessments were performed at baseline and at weeks 2, 4, and 6 after treatment initiation.
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Roasted Nux Vomica Capsules is a hospital preparation approved by Zhejiang Provincial Medical Products Administration (Approval No.: Zhe Yao Zhi Zi Z20100263).
Each capsule contains 0.2 g of processed Strychnos nux-vomica L. seed powder.
Patients take 2 capsules (0.4 g) orally three times daily with warm water after meals for 6 consecutive weeks.
All patients continue their original bortezomib-based chemotherapy regimen during the study period.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in NCI-CTCAE grade from Baseline to Week 6
Prazo: Baseline, Week 2, Week 4, and Week 6 after treatment initiation
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Change in peripheral neuropathy grade as assessed by the NCI-CTCAE version 4.0.
Grades range from 0 (no neuropathy) to 4 (life-threatening neuropathy).
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Baseline, Week 2, Week 4, and Week 6 after treatment initiation
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in FACT/GOG-NTx Neurotoxicity Score from Baseline to Week 6
Prazo: Baseline, Week 2, Week 4, and Week 6 after treatment initiation
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Change in patient-reported neurotoxicity as measured by the FACT/GOG-NTx scale.
Higher scores indicate worse neurotoxicity.
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Baseline, Week 2, Week 4, and Week 6 after treatment initiation
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in TCM syndrome score
Prazo: Baseline, Week 2, Week 4, and Week 6 after treatment initiation
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Change in TCM syndrome score for peripheral neuropathy, which includes symptoms such as limb pain, numbness, coldness, and weakness.
Higher scores indicate more severe symptoms.
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Baseline, Week 2, Week 4, and Week 6 after treatment initiation
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Colaboradores e Investigadores
Investigadores
- Investigador principal: Shu Deng, The First Affiliated Hospital of Zhejiang Chinese Medical University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças do Sistema Nervoso
- Doenças Vasculares
- Doenças cardiovasculares
- Processos Patológicos
- Neoplasias
- Doenças do sistema imunológico
- Neoplasias por Tipo Histológico
- Inflamação
- Doenças Hematológicas
- Distúrbios Linfoproliferativos
- Distúrbios imunoproliferativos
- Neoplasias de Células Plasmáticas
- Distúrbios hemostáticos
- Paraproteinemias
- Distúrbios das Proteínas Sanguíneas
- Distúrbios hemorrágicos
- Condições Patológicas, Sinais e Sintomas
- Doenças hemic e linfáticas
- Doenças Neuroinflamatórias
- Mieloma múltiplo
Outros números de identificação do estudo
- 2021-K-263-01
- 2021ZB092 (Número de outro subsídio/financiamento: Zhejiang TCM Administration)
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
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